JJIClass I

Analyzer, Enzyme, For Clinical Use

Clinical Chemistry · 21 CFR 862.2500

MDR events6All time

Recalls1All time

Registered firms7Currently listed

510(k) clearances8All time

Recent MDR events

6 adverse event reports on file

Event type breakdown

Malfunction4

Unspecified1

Injury1

Most-reported manufacturers

Abbott Laboratories3 Unspecified1 Beckman Coulter, Inc.1 Bio-rad Laboratories, Inc.1

Recalls

1 recall events for this product code

Abbott Laboratories MPG
TerminatedMar 8, 2007
ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064;
The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.
Z-0413-2007 · View FDA record ↗

Registered firms

7 firms currently registered for this product code

510(k) clearances

8 clearances for this product code